MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	HAR36
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed an indentation in the teflon pad and evidence of clinical use.The tip of the distal end of the blade was broken off and not returned with the device.The jaw, teflon pad, and contact rings appear to be intact.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: - jaws/blade subassembly damage.- incidental and prolonged activation against solid surfaces, such as bone or plastic.The instructions for use (ifu) state: - avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.- incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.- close the trigger.Remove the torque wrench by sliding it off of the shaft.Do not dispose of the torque wrench until the procedure is completed.The torque wrench is used to remove the instrument from the hand piece following the procedure.Dispose the torque wrench only after completing the procedure.Note: take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or off of the shaft.Note: take care to avoid injury from the blade tip while sliding the torque wrench onto or off of the shaft.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the tip of the harmonic scalpel (har36) broke.The device was replaced to complete the procedure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 7038064
• Report Number: 0001056128-2017-00135
• Device Sequence Number: 926779
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)180801(10)6828964
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K133672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 6828964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1